The European Commission (EC) has approved Aubagio (teriflunomide) for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS). The EC approval is based on data from the Phase 3 TERIKIDS study. The approval confirms Aubagio as the first oral multiple sclerosis (MS) therapy for first-line treatment of children and adolescents with MS in the European Union.
MS affects an estimated 2.8 million people around the world, with children and adolescents representing at least 30,000 of those impacted. Pediatric MS is a rare condition and onset follows a relapsing-remitting disease course in 98 percent of pediatric patients. Compared with adult-onset MS, pediatric patients often present with higher relapse rates and a greater lesion burden. Due to the earlier onset of disease, irreversible disability and secondary progression often occur at an earlier age than with adult counterparts. The symptoms of MS can impact all aspects of a young person’s life from physical health to social development and self-esteem.
“Pediatric multiple sclerosis remains an area of significant unmet medical need,” said Erik Wallström, MD, PhD, Therapeutic Area Head, Neurology Development at Sanofi Genzyme. “The European approval of Aubagio in pediatrics means young people with MS have a new treatment option, and importantly – one that can offer meaningful improvement in managing this serious disease.”
Aubagio was initially approved in the EU in 2013 for the treatment of adult patients with RRMS and the EC approval for the pediatric indication provides an additional year of marketing protection in the European Union.